A discontinuous reverse micellar composition in cubic fd3m phase for sustained release of therapeutic drugs
AssigneeCouncil of Scientific and Industrial Research
InventorsGuruswamy Kumaraswamy, Manoj Kumar, Ashootosh Vasant Ambade
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Abstract
The present invention discloses reverse/inverse micellar discontinuous cubic phase (Fd3m phase) composition for controlled release of therapeutic drugs or biologically active component and to the process for preparation thereof.
Claims11
A stable, discontinuous reverse micellar composition stacked in a cubic Fd3m phase comprising:
- i. a moiety ‘A’ selected from water soluble branched polymer with molecular weight in the range of 0.5-5 kDa or polar interacting particles of size less than 5 nm or molecular cages of size less than 5 nm;
- ii. moiety ‘B’ lipids and
- iii. moiety ‘C’ a hydrophilic phase;
- wherein weight fraction of moiety ‘C’ relative to moiety ‘B’ is in the range of 10-40 wt %;
- moiety ‘A’ is in the ratio 0.5-10 wt % relative to moiety ‘B’ and moiety ‘C’.
A process for preparation of stable, discontinuous reverse micellar composition stacked in to Fd3m phase comprising the steps of:
- i. mixing 0.5-10 wt % water soluble polar branched polymer of molecular weight 0.5-5 kDa or polar interacting particles of size less than 5 nm or molecular cages of size less than 5 nm to a solution of lipid and water followed by addition of 30% (v/v) HNO3 to adjust the pH of the polymer in solution to pH 10;
- and
- ii. heating the mixture as obtained in step (i) at a temperature in the range of 60-80° C. and allowing the mixture to equilibrate for a period of 10-15 days to obtain stable, discontinuous reverse micellar composition stacked in to Fd3m phase.
The method for sustained release of an active selected from pharmaceutical drug or biologically active component comprising administering to a subject in need thereof an effective amount of pharmaceutical composition comprising discontinuous reverse micelles stacked in a cubic Fd3m phase and an active.
Dependencies are inferred from the claim text.